Clinuvel

macgyver

Well-known member
It’s on everyone’s minds now. No mention of Clinuvel.

Alzheimer’s Decision Sends Positive Message to Aussie Biotechs”



“The FDA’s apparent attitudinal shift is also relevant for stem-cell therapy developer Mesoblast (ASX:MSB), as it prepares to re-submit an approval application for its graft-versus-host disease treatment Remestemcel-L”

“In a reverse of the Biogen experience, an FDA expert committee last year voted nine-to-one in favour of approving the application, but the agency itself knocked back the entreaty for want of deeper clinical evidence.”


Lol. Cancel the FDA expert committee. Pointless appendage🤷🏽‍♂️
 
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Toktok

Well-known member
Part of the frustration for long term shareholders in clinuvel has been the endlessly dragged out approval, ethical procedures for everything cub does. Phase 3 EPP had to be repeated 3 times, ema decisions were delayed for almost two years, FDA cannot stop pondering over vitiligo trial protocols. Months after the first XP patient is treated their is no reported progress in the trial. VP is a big question mark still, a 6th indication waiting...for what? The cosmetics production partner cannot produce anything since the launch failure of May 2018. In the backdrop of this we are constantly bombarded with approvals and fast tracking of drugs that have seemingly no measurable positive effect of any sort.
Companies are multiplying market cap while cuv has a measly 18 k shares traded in a day with a 2 years sideways movement after FDA approval and this with triple approval and a constant business growth.

My experience with those fast boys is that eventually the market and clinical reality catches up.
1: it does not work and/or could be dangerous
2: nobody in the medical world will want to buy it for administration to patients
3: eventually patients or their family will find out and also resist ever using this drug
4: sp decline

No wonder people resign in protest. Who wants to have their name connected to failures like this?

For cuv and Scenesse the path is different.
Safe
Commercially/clinically proven worthy
Patients keep coming back.
Applications expanding gradually.

Makes me think that the FDA question to patients was possibly hinting at approved recell spray on skin for vitiligo treatment.
 

Sherlock

Well-known member
Part of the frustration for long term shareholders in clinuvel has been the endlessly dragged out approval, ethical procedures for everything cub does. Phase 3 EPP had to be repeated 3 times, ema decisions were delayed for almost two years, FDA cannot stop pondering over vitiligo trial protocols. Months after the first XP patient is treated their is no reported progress in the trial. VP is a big question mark still, a 6th indication waiting...for what? The cosmetics production partner cannot produce anything since the launch failure of May 2018. In the backdrop of this we are constantly bombarded with approvals and fast tracking of drugs that have seemingly no measurable positive effect of any sort.
Companies are multiplying market cap while cuv has a measly 18 k shares traded in a day with a 2 years sideways movement after FDA approval and this with triple approval and a constant business growth.

My experience with those fast boys is that eventually the market and clinical reality catches up.
1: it does not work and/or could be dangerous
2: nobody in the medical world will want to buy it for administration to patients
3: eventually patients or their family will find out and also resist ever using this drug
4: sp decline

No wonder people resign in protest. Who wants to have their name connected to failures like this?

For cuv and Scenesse the path is different.
Safe
Commercially/clinically proven worthy
Patients keep coming back.
Applications expanding gradually.

Makes me think that the FDA question to patients was possibly hinting at approved recell spray on skin for vitiligo treatment.
Yes, agreed, however, the risk for CUV is they will be labeled as one of the 'newcomers' in a hot market with a multitude of drugs who have a measly effect. Next to having a drug for a till now non curable symptom, due to the delays they now enter an increasingly crowded market with a lot of 'junk'. So, besides the difficulties with the authorities, they now have to battle and convince not only that the drugs work, they additionally have to convince (again) they are not junk because the opinion will be all drugs in that area are junk. The market area got stained. CUV has to show they are not jumping on a bandwagon. It is hard to get that opinion shed off. It could be competition is doing this on purpose, but that seems a bit too much tin foil hat for me, but well. Just saying.

Of course, we know about the safety profile; but for SP movement you need new flesh in the shareholder pool and thus you need to convince general public. Waiting for your competitors to be weeded out by mediocre results is watching paint dry. We have the risk of losing the advantage of entering a new market. No-one recalls the second man on the moon.

I realize I've answered my own question of a few days ago.
 
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Alexius

Active member
@Sherlock Isn't there also a substantial risk that Afamelanotide is lacking efficacy in treating Stroke, DNA repair and CNS diseases? I'm a bit surprised that "safety awareness" is considered to be the major risk. If there is any evidence that Afamelanotide is highly likely to work, please share these insights...I'll then take a loan and go all in CUV :)
 

Sherlock

Well-known member
@Sherlock Isn't there also a substantial risk that Afamelanotide is lacking efficacy in treating Stroke, DNA repair and CNS diseases? I'm a bit surprised that "safety awareness" is considered to be the major risk. If there is any evidence that Afamelanotide is highly likely to work, please share these insights...I'll then take a loan and go all in CUV :)
Absolutely, I don't know the outcome; and irrespective of the efficacy; that doesn't say a lot on how FDA will decide (see Biogen). However, the risk you mention was always there; what I mention is now added to the pile of risks. CUV is gaining foothold in EPP; if it is somehow flushed away because of an false imago being built around these drugs, you went from shit till worse. For the record; I fully believe in the product, and I don't see it as likely, but dirtier games have been played. And maybe I'm seeing issues which aren't dare, could be. I don't know.
And never take a loan to buy shares. My common sense advise. Spare what you can; but don't stick your neck in unnecessary ropes.
 
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Klomp

3rd Longest Active Member
@Alexius Completely agree here. i think sometimes we on this Board under-estimate the risk associated with approval of future indications. There is a tendency to bank an indication the moment its announced. A lot needs to go right. I think this is why the share price will linger between $20 - $30 until the market sees real proof that the company is able to progress on its strategy. They are great announcing aspirations, but so far have a very low conversion rate on their objectives...EPP being the one exception.
 

KRD

Well-known member
@Klomp Certainly in a trading lull this week. US market is dead with virtually no activity. I’m starting to agree that being on NASDAQ would be beneficial. However, it may not even be of interest to management. The end game may be to just get a couple more indications approved, build up the pipeline and get a hefty buyout from big Pharma. I could see it happening in the next 3 years.
 

Justinian

Well-known member
@Klomp Certainly in a trading lull this week. US market is dead with virtually no activity. I’m starting to agree that being on NASDAQ would be beneficial. However, it may not even be of interest to management. The end game may be to just get a couple more indications approved, build up the pipeline and get a hefty buyout from big Pharma. I could see it happening in the next 3 years.
Would big pharma have any interesting in some of the things Clinuvel has been doing recently though, such as manufacturing and the new labs in Singapore? I'd imagine big pharma wouldn't care much about that stuff since they have their own resources.
 

KRD

Well-known member
Would big pharma have any interesting in some of the things Clinuvel has been doing recently though, such as manufacturing and the new labs in Singapore? I'd imagine big pharma wouldn't care much about that stuff since they have their own resources.
The same thought crossed my mind. CUV stated they really believe in vertical integration to control the whole process. If big Pharma comes in with a $5 or $10 billion buyout the cost of any manufacturing/new lab facilities CUV expended will be a drop in the bucket. Big Pharma could keep those new facilities and run a CUV subsidiary as a fairly independent operation or just close them and expense the costs.

I’ve said before that CUV is not set up to be a global pharmaceutical company with tens or hundreds of thousands of patients. Once other indications are approved they will need to partner up or sell out to big Pharma. PW and some of the senior managers have been at this for a long time. We can pretty much assume PW will leave after his next contract extension. Certainly could see others, including board members, deciding that as well. There would be a great feeling of accomplishment among all of them .
 

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